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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / February 2026 / K251732

510(k) cleared

Wrist Fracture System

Met One Technologies, LLC · Feb 12, 2026 · K251732

FDA cleared the Wrist Fracture System from Met One Technologies, LLC on Feb 12, 2026 under K251732, a traditional 510(k). The device falls under product code HRS, Plate, Fixation, Bone, regulated at 21 CFR 888.3030 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jun 6, 2025. The decision came 251 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Met One Technologies, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251732?

K251732 is the FDA 510(k) for Wrist Fracture System, submitted by Met One Technologies, LLC. FDA's decision date was Feb 12, 2026, under product code HRS (Plate, Fixation, Bone).

Who makes the Wrist Fracture System?

Met One Technologies, LLC, based in El Paso, TX, is the applicant of record for K251732.

How long did the K251732 review take?

FDA received the submission on Jun 6, 2025 and issued its decision on Feb 12, 2026, 251 days later.

← All decisions in February 2026